Abstract:
OBJECTIVES:Terameprocol (M4N, EM-1421) is a novel transcription inhibitor that selectively interferes with HPV viral genes E6/E7 with Sp1-dependent promoters, and induces apoptosis by inactivation of the CDC2/cyclin B complex (maturation promoting factor) and production and phosphorylation of survivin. This trial was designed to define the maximum tolerated dose (MTD), dose-limiting toxicity and determine the pharmacokinetic profiles of intravaginal terameprocol in women with HPV-linked cervical squamous intraepithelial neoplasia. METHODS:An open label, dose escalation Phase I/II clinical trial enrolled women with biopsy confirmed CIN 1, 2 or 3. Terameprocol (45 or 90 mg) was physician-administered directly to the cervix uteri in 3 once weekly applications. The pharmacokinetics after administration were examined on Day 1 of dosing. Patients underwent colposcopic examinations, HPV testing, biomarker assessments, cytology and cervical punch biopsy. RESULTS:Recruitment ended March 30, 2006 and 7 patients were enrolled. Median age was 24 years. There were no serious adverse events (SAEs) and possible treatment-related Adverse Events (AEs) reported were mild and self-limiting. There was no detectable absorption of terameprocol from the vaginal ointment application. CONCLUSIONS:Terameprocol in 1% and 2% vaginal ointment use in Phase I/II trials with women with HPV-linked cervical intraepithelial neoplasia has an excellent safety profile, no SAEs reported and mild, self-limiting treatment-related AEs. There was no detectable absorption of terameprocol. These data support the continued evaluation of terameprocol in in vitro and animal efficacy models followed by definitive human Phase II clinical trials in CIN.
journal_name
Gynecol Oncoljournal_title
Gynecologic oncologyauthors
Khanna N,Dalby R,Tan M,Arnold S,Stern J,Frazer Ndoi
10.1016/j.ygyno.2007.08.074subject
Has Abstractpub_date
2007-12-01 00:00:00pages
554-62issue
3eissn
0090-8258issn
1095-6859pii
S0090-8258(07)00645-2journal_volume
107pub_type
杂志文章,多中心研究abstract:OBJECTIVE:Incorporating topotecan into standard platinum/taxane chemotherapy for advanced ovarian cancer has been complicated by myelosuppression. This study evaluated sequential doublets of topotecan and carboplatin, followed by paclitaxel and carboplatin, in newly diagnosed advanced ovarian cancer patients. METHODS:...
journal_title:Gynecologic oncology
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1016/j.ygyno.2004.05.021
更新日期:2004-08-01 00:00:00
abstract::Steroid cell tumors, not otherwise specified, are rare ovarian sex cord-stromal tumors with malignant potential. The majority of these tumors produce steroids with testosterone being the most common. A case of a 46-year-old woman who presented with sudden onset of virilization and a pelvic mass is reported. Various as...
journal_title:Gynecologic oncology
pub_type: 杂志文章,评审
doi:10.1006/gyno.1999.5549
更新日期:1999-11-01 00:00:00
abstract::The causes of death in long-term survivors after resection of cervical cancer were investigated in a follow-up study of 375 women, focusing especially on the postoperative development of second primary cancers. The 5- and 10-year overall survival rates were 75.0 and 66.0%, respectively, in cases that showed frank inva...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1006/gyno.1995.1011
更新日期:1995-01-01 00:00:00
abstract:OBJECTIVE:Binding of Fas ligand or agonistic anti-Fas antibody to the death receptor Fas can activate a caspase-cascade resulting in apoptosis. In the present study, the functionality of the Fas pathway was studied in human cervical cancer cells with different HPV and p53 status. METHODS:HeLa (HPV-18 positive), CaSki,...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2005.01.036
更新日期:2005-05-01 00:00:00
abstract:OBJECTIVE:Many gynecologic oncology (GO) patients in Virginia are low income and their care is supplemented by Disproportionate Share Hospital (DSH) funds. Our objective is to estimate how many new GO patients may lose access to care if the state forgoes Medicaid expansion. METHODS:New patients referred to the GO serv...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2013.04.468
更新日期:2013-08-01 00:00:00
abstract::Hypersensitivity reactions to intravenous administration of carboplatin (CP) have been previously reported. However, hypersensitivity reaction to intraperitoneal administration of CP has not yet been reported. A 66-year-old woman diagnosed with ovarian carcinoma underwent six courses of intraperitoneal administration ...
journal_title:Gynecologic oncology
pub_type: 杂志文章,评审
doi:10.1006/gyno.1998.5273
更新日期:1999-03-01 00:00:00
abstract:OBJECTIVE:We wanted to identify genes up-regulated in ovarian tumors that might serve as early markers for ovarian cancer. One promising focus is the family of genes that encode secreted proteases, which play essential roles in tumor invasion and metastasis. Kallikrein 10 (KLK10) is a member of the kallikrein family of...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/s0090-8258(03)00257-9
更新日期:2003-07-01 00:00:00
abstract::Uterine papillary serous carcinoma (UPSC) is an aggressive histologic subtype of endometrial cancer. Currently, no effective chemotherapy regimens exist. We report a case of complete response of a stage IV UPSC to neoadjuvant chemotherapy with Taxol and carboplatin. ...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1006/gyno.1999.5361
更新日期:1999-06-01 00:00:00
abstract:OBJECTIVE:Effective communication improves patient outcomes and is crucial to good patient care. Communication skills training (CST) has been shown to improve communication skills in non-gynecologic oncology specialties. We sought to develop and test CST for gynecologic oncology (GO) providers. METHODS:We developed an...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2019.03.242
更新日期:2019-06-01 00:00:00
abstract:OBJECTIVE:Wee1-like kinase (Wee1) is a tyrosine kinase which negatively regulates entry into mitosis at the G2 to M-phase transition and has a role in inhibition of unscheduled DNA replication in S-phase. The present study investigated the clinical role of Wee1 in advanced-stage (FIGO III-IV) ovarian serous carcinoma. ...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2014.07.102
更新日期:2014-10-01 00:00:00
abstract::Routine endocervical curettage has been advocated in the colposcopic evaluation of patients with abnormal cervical cytology. To assess the usefulness of this procedure, we reviewed the records of 518 patients referred to the Colposcopy Clinic with abnormal Pap smears. Data was reviewed retrospectively in 411 patients ...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/0090-8258(86)90100-9
更新日期:1986-10-01 00:00:00
abstract::Wound healing has evolved from gauze therapy to the use of proteomics, gene therapy, and cellular-based therapies in the short time span of 45 years. Education for health care providers has not kept pace with the logarithmic acceleration in technology development and treatment options. A patient with a non-healing wou...
journal_title:Gynecologic oncology
pub_type: 杂志文章,评审
doi:10.1016/j.ygyno.2008.07.054
更新日期:2008-11-01 00:00:00
abstract:OBJECTIVE:To determine the relationship between history of cervical dysplasia or carcinoma and the development of cervical dysplasia or adenocarcinoma in women who have a diagnosis of atypical glandular cells of undetermined significance (AGUS), favor endocervical origin, or AGUS, not otherwise specified. METHODS:A 6-...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1006/gyno.1999.5512
更新日期:1999-09-01 00:00:00
abstract:PURPOSE:This report describes the strength and significance of the association between antecedent and mediating variables across four categories of quality of life (QOL) outcomes in 132 disease free women with ovarian germ cell survivors. METHODS:Survivors (n=132) participated in a mailed questionnaire and computer-as...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2007.01.042
更新日期:2007-06-01 00:00:00
abstract::Angiomyofibroblastoma is a rare, myxoid tumor of the vulva. To date only 12 cases have been reported in the world literature. Patients are usually premenopausal and present with a vulval mass initially diagnosed as a Bartholin's cyst. The lesions are well circumscribed and range from 0.5 to 12 cm in size. Microscopica...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1006/gyno.1994.1230
更新日期:1994-09-01 00:00:00
abstract:BACKGROUND:Metformin has been associated with reduced cancer risk. The mechanisms underlying this cancer protective effect remain unknown. METHODS:"Window of opportunity" study of metformin in women with operable endometrial cancer (EC). Eleven newly diagnosed, untreated, non-diabetic patients with EC received metform...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2014.06.014
更新日期:2014-09-01 00:00:00
abstract:BACKGROUND:A case of primary neuroblastoma arising from the broad ligament with excellent response to neoadjuvant bleomycin, etoposide, and cisplatin (BEP) is reported. CASE:A 48-year-old woman, G0, who presented with acute renal failure, an enlarged pelvic mass, and abdominal pain was diagnosed with adult neuroblasto...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2007.06.027
更新日期:2007-11-01 00:00:00
abstract::To determine how patients with invasive cervical cancer present and whether presentation affects disease-free survival (DFS), a review of 81 patients treated for cervical cancer by the Division of Gynecologic Oncology and Pelvic Surgery at the Southern California Permanente Medical Group between January 1, 1986, and D...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/0090-8258(91)90229-x
更新日期:1991-07-01 00:00:00
abstract:BACKGROUND:Chemotherapy remains an essential part of the treatment of advanced ovarian cancer. Intraperitoneal (IP) administration has been demonstrated to provide a survival advantage over intravenous chemotherapy in three phase 3 studies. However, IP catheter complications have been a significant factor in aborting I...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2007.12.029
更新日期:2008-12-01 00:00:00
abstract:OBJECTIVE:To compare the frequencies of somatic homologous recombination (HR) gene mutations identified in next-generation sequencing (NGS) genomic profiling of uterine serous carcinomas (USCs) and high-grade serous ovarian carcinomas (HGSOCs). METHODS:Data for this analysis was obtained from AACR Project GENIE, a mul...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2020.08.012
更新日期:2020-11-01 00:00:00
abstract::The altered expression of histocompatibility leukocyte antigens (HLA) in the development to cervical carcinoma suggests that tumor progression may be related to impaired recognition by host immune defense mechanisms. To investigate whether this phenomenon plays a role in the process of metastasis of cervical cancer, w...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1006/gyno.1995.1156
更新日期:1995-06-01 00:00:00
abstract:OBJECTIVE:Epidemiologic data suggest that aberrant androgen homeostasis may promote aggressive epithelial ovarian cancer biology. Hyperandrogenism results from both obesity and expression of polymorphic androgen receptor (AR) allelotypes harboring short cytosine-adenine-guanine (CAG) repeat sequences; both have been sh...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2007.07.059
更新日期:2007-12-01 00:00:00
abstract:OBJECTIVES:Lymph node status is an important prognostic factor in patients with squamous cell carcinoma (SCC) of the vulva. Complete inguinofemoral lymph node dissection (ILND) is accompanied by a high morbidity. Sentinel lymph node biopsy (SLNB) was established for less invasive lymph node (LN) staging. The aim of thi...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2008.04.004
更新日期:2008-09-01 00:00:00
abstract:OBJECTIVE:Many studies have examined the relationship between worry and cancer screening. Due to methodological inconsistencies, results of these studies have varied and few conclusions can be made when generalizing across studies. The purpose of the current study was to better understand the worry-cancer screening rel...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2016.11.047
更新日期:2017-02-01 00:00:00
abstract:OBJECTIVE:To define a prognostic score based on pretreatment values of leucocyte, platelet and hemoglobin in locally advanced cervical cancer (LACC). MATERIAL AND METHODS:We conducted a prospective study of 238 patients for LACC with negative PET imaging in the para-aortic (PA) area and who were undergoing laparoscopi...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2020.08.002
更新日期:2020-11-01 00:00:00
abstract::From July 1975 through December 1985, 328 patients with ovarian malignancies were treated. Of these, 302 had epithelial invasive malignancies and constitute the study group. The impact of the operative procedure, findings, and subsequent treatment is evaluated. Patients who underwent extensive debulking procedures suc...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/0090-8258(90)90277-r
更新日期:1991-03-01 00:00:00
abstract:BACKGROUND:Ovarian tumors in the pediatric population are most likely to be of germ cell origin. However, serous tumors have also been reported in adolescent patients. CASE:A 14-year-old girl was diagnosed with stage IIIc low-grade ovarian cancer. Her serum CA-125 was elevated preoperatively and was a marker for recur...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1006/gyno.2000.6020
更新日期:2001-01-01 00:00:00
abstract:BACKGROUND:The combination ascites, pleural effusion, and elevated CA 125 are usually associated with a malignancy. CASE:A 38-year-old SLE patient consulted her physician for shortness of breath. On clinical examination, she had a tender abdomen and reduced breathing sounds. X-ray and computed tomography of the chest ...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2004.12.022
更新日期:2005-04-01 00:00:00
abstract:OBJECTIVES:We aimed to evaluate whether carboplatin has a comparable efficacy with cisplatin as part of weekly concurrent chemoradiotherapy for cervical cancer (Car-RT vs. Cis-RT). METHODS:A literature search was conducted and both prospective and retrospective studies that evaluated the efficacy of Car-RT for cervica...
journal_title:Gynecologic oncology
pub_type: 杂志文章,meta分析,评审
doi:10.1016/j.ygyno.2018.07.005
更新日期:2018-09-01 00:00:00
abstract:OBJECTIVE:In Denmark, the proportion of women with ovarian cancer treated with neoadjuvant chemotherapy (NACT) has increased, and the use of NACT varies among center hospitals. We aimed to evaluate the impact of first-line treatment on surgical outcome and median overall survival (MOS). METHODS:All patients treated in...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2013.11.035
更新日期:2014-02-01 00:00:00